BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8847453 · Received July 31, 2019

    Report

    Report Number
    2023826-2019-01276
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    July 3, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 SHOULD HAVE BEEN INCLUDED IN INITIAL MDR. PATIENT CODE 3191 CORRECTED TO: PUPILLARY EDEMA, MEDICAL INTERVENTION, EXPLANT, LASIK. PATIENT CODE 1822 SHOULD HAVE BEEN INCLUDED IN INITIAL MDR. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE: UNK, NO SERIAL NUMBERS REPORTED. (B)(4).

    Description of Event or Problem · 1

    ON 03 JULY 2019 WE RECEIVED NOTIFICATION OF AN ARTICLE PUBLISHED IN CZECH AND SLOVAK JOURNAL OF OPHTHALMOLOGY ENTITLED, 'INCIDENCE OF CATARACT FOLLOWING IMPLANTATION OF POSTERIOR- CHAMBER PHAKIC LENS ICL (IMPLANTABLE COLLAMER LENS) LONG TERM RESULTS.' THE ARTICLE ANALYZES THE RESULTS OF ICL IMPLANTATION IN 34 PATIENTS FROM 1998 TO 2013. ONE SUCH CASE REFERENCES THE RECURRENCE OF UVEITIS IN ONE MYOPIC EYE. UVEITIS OCCURRED THREE TIMES FOLLOWING IMPLANTATION OF AN ICM V4 LENS, ALWAYS APPROXIMATELY WITHIN AN INTERVAL OF ONE MONTH, THE LAST ATTACK LEADING TO THE DEVELOPMENT OF CYSTOID MACULAR EDEMA AND PAPILLARY EDEMA. THE PATIENT WAS REPEATEDLY TREATED WITH CORTICOIDS LOCALLY AND GENERALLY ORALLY, ONCE INTRAVENOUSLY. ONE YEAR AFTER IMPLANTATION OF ICL, THE LENS WAS EXPLANTED. FOLLOWING THE TERMINATION OF CORTICOID THERAPY AND THREE YEARS AFTER EXPLANTATION OF THE ICL , THE PATIENT UNDERWENT LASIK FOR CORRECTION OF REFRACTIVE ERROR. NOW, 8 YEARS AFTER IMPLANTATION OF ICL, THE PATIENTS IS WITHOUT COMPLAINTS, UCVA IN THE RIGHT AND LEFT EYE ATTAINS 1.0. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641836 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention